RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial

Launched by HARBIN MEDICAL UNIVERSITY · Jun 5, 2024

Keywords

ClinConnect Summary

The RESTORE Imaging trial is studying a treatment called drug-coated balloons (DCB) to see if they can better stabilize certain types of heart artery blockages, known as vulnerable plaques, in patients experiencing acute coronary syndrome (ACS), which includes conditions like heart attacks and unstable angina. This study aims to compare DCB treatment with standard medications to determine which is more effective in improving heart health for these patients.

To be eligible for this trial, participants should be between 18 and 80 years old, have had a recent heart attack or unstable angina, and need a specific type of heart procedure called percutaneous coronary intervention (PCI). They must also have certain characteristics in their heart arteries, such as blockages that are not too severe but still require attention. If you join the study, you can expect regular check-ups and monitoring as researchers evaluate how well the DCB treatment works compared to standard care. It’s also important to note that individuals with certain health issues or who are already participating in other clinical studies may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must be between 18 and 80 years of age
• • 2. Subject must present with acute myocardial infarction or unstable angina planned for PCI
• • 3. Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8)
• • 4. Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR \>0.8
• • 5. Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
• • 6. Target lesion must have any two of the intravascular imaging criteria of PB \>65%, MLA \<3.5 mm\^2 (OCT) or 4.0mm\^2 (IVUS), FCT \<75 μm, or maximal lipid arc \>180°
• • 7. Subject must provide written informed consent before any study-related procedure
• Exclusion Criteria:
• • 1. Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated
• • 2. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.)
• • 3. Hypotension, shock, or need for mechanical support or intravenous vasopressors;
• • 4. Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR)
• • 5. Left ventricular ejection fraction\<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
• • 6. Life expectancy \<2 years for any
• • 7. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
• • 8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• • 9. The target lesion is located within 10 mm of the proximal or distal of stent
• • 10. The target lesion cannot be in the left main coronary artery
• • 11. The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is \>2 mm with \>50% of stenosis)
• • 12. The target lesion is located in severe calcification or tortuosity of vessels
• • 13. The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
• • 14. The target lesion is located within the bypass graft artery